Deep Versus Moderate Neuromuscular Blockade During Laparoscopic Surgery



Status:Enrolling by invitation
Conditions:Prostate Cancer, Cervical Cancer, Cancer, Renal Impairment / Chronic Kidney Disease, Women's Studies, Women's Studies, Gastrointestinal, Gastrointestinal, Gastrointestinal, Endometriosis
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Oncology, Other, Reproductive
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:December 27, 2016
End Date:May 2019

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Effect of Deep Versus Moderate Neuromuscular Blockade on Peak Airway Pressures During Elective Laparoscopic Surgery

This is a two period cross-over study randomizing patients undergoing laparoscopic surgery
into 2 different groups: group 1 in which patients receive "deep neuromuscular blockade" in
the beginning portion of their laparoscopic surgery followed by a period of "moderate
blockade" and, group 2 in which patients receive "moderate neuromuscular blockade" in the
beginning portion of their laparoscopic surgery followed by a period of "deep blockade". The
deep neuromuscular block is defined as post tetanic count of 1 to 2 and the moderate
neuromuscular block is defined as 1-2 twitches. In all patients, sugammadex is used to
reverse the block at the end of surgery in order to obtain optimal extubating conditions.

Neuromuscular blockade (NMB) is frequently utilized in laparoscopic procedures to improve
surgical conditions by relaxing the abdominal muscles and thus facilitating insufflation with
carbon dioxide to optimize surgical view. Increased airway pressures can lead to an increase
in alveolar and perivascular edema, a decline in dynamic lung compliance and hypoxemia.

Several studies have investigated surgical view under deep vs. moderate neuromuscular
blockade. Literature supports deep neuromuscular blockade providing better operating
conditions/view by a surgeon and low airway pressures but, potentially, longer duration to
extubation and worse respiratory mechanics at the end of anesthesia versus moderate
neuromuscular blockade which shows worse operating conditions/view by a surgeon and worse
airway pressures but possibly shorter duration to extubation and better respiratory mechanics
at the end of anesthesia.

Thus, there is clearly equipoise with regard to the comparative effectiveness of deep vs
medium NMB. Therefore, this study is designed to ascertain if a deep neuromuscular block will
decrease the airway pressures in patients undergoing laparoscopic procedures compared to
those under a moderate block. A reduction in airway pressures may lead to a decrease in the
complications associated with elevated airway pressures including hypoxemia, total static
lung compliance, alveolar edema, and long term morbidity. Additionally, the study aims to
determine if time from administration of sugammadex to reversal is different between patients
that have a moderate NMB as compared to a deep NMB.

Inclusion Criteria:

- Each participant must be willing and able to provide written informed consent for the
study.

- Each participant must be American Society of Anesthesiologists (ASA) class I, II or
III.

- Each participant must be scheduled for elective laparoscopic surgery (this includes
robotic laparoscopic surgery).

- Expected surgical duration of 60 min or longer

Exclusion Criteria:

- Inability to give informed oral or written consent

- Known or suspected neuromuscular disorders impairing neuromuscular function;

- True allergies as defined as hypotension, bronchospasm, or anaphylaxis to muscle
relaxants, anesthetics or opioids

- A history (patient or family) of malignant hyperthermia

- A contraindication for neostigmine administration

- Renal insufficiency, as defined by serum creatinine levels at 2.5 fold the normal
level

- Body mass index >40 kg/m^2

- Significant respiratory disease.

- Planned postoperative mechanical ventilation
We found this trial at
1
site
Stony Brook, New York 11794
Principal Investigator: Ruchir Gupta, MD
Phone: 631-638-1214
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mi
from
Stony Brook, NY
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